Efficacy of Fresh Frozen Plasma (FFP) in Treating Thrombocytopenia in Dengue Patients

NCT06642493 | Active Not Recruiting DMC

• 1 other identifier: SHNIBPS: June2024/03
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial seeks to assess the effectiveness of fresh frozen plasma (FFP) in the treatment of thrombocytopenia in individuals with dengue. Dengue is a viral infection marked by thrombocytopenia, potentially resulting in significant hemorrhagic consequences. FFP is frequently utilized in the management of coagulopathies, and this study will investigate its efficacy in enhancing platelet count and mitigating bleeding risks in dengue patients with thrombocytopenia. The research will be executed as a randomized, controlled trial to evaluate outcomes in patients receiving routine care with and without FFP transfusion.

Conditions

Dengue Fever; Dengue Hemorrhagic Fever; Dengue Shock Syndrome

Keywords

Dengue fever; Thrombocytopenia; Plasma transfusion; Elevated aPTT; Coagulopathy in dengue; Non-bleeding dengue complications; Hemostatic management in dengue

Outcome Measures

Primary Outcomes (1)

• Change in aPTT values from baseline to 24 and 48 hours post-transfusion.

  Platelet count change from baseline (pre-intervention) to 48 hours post-transfusion. CBCs will be performed before FFP administration and 24 and 48 hours post-transfusion to measure platelets. The purpose is to determine if fresh frozen plasma (FFP) enhances platelet count in dengue-related thrombocytopenia patients compared to usual therapy without FFP.

  24 to 48 hours

Secondary Outcomes (1)

• Incidence of bleeding complications within 7 days post-transfusion, changes in other coagulation parameters (PT, fibrinogen levels) from baseline to 24 and 48 hours post-transfusion, platelet count changes post-transfusion, length of hospital stay, and o

  30 days

Study Arms (2)

Arm 1: Intervention Arm Title: Plasma Transfusion.

EXPERIMENTAL

Arm 1: Intervention Arm Title: Plasma Transfusion Description: Participants in this arm will receive fresh frozen plasma (FFP) transfusion at a dose of 10-15 mL/kg body weight. Intervention: Type: Biological Name: Fresh Frozen Plasma (FFP) Description: Administration of FFP to correct coagulopathy and normalize aPTT.

Biological: Fresh frozen plasma

Arm 2: Control Arm Title: Standard Supportive Care

PLACEBO COMPARATOR

Arm 2: Control Arm Title: Standard Supportive Care Description: Participants in this arm will receive standard supportive care without plasma transfusion. Intervention: Type: Other Name: Standard Supportive Care Description: Standard medical management without the administration of plasma transfusion.

Biological: Fresh frozen plasma

Interventions

Fresh frozen plasma BIOLOGICAL

Intervention Type: Biological * Intervention Name: Fresh Frozen Plasma (FFP) * Detailed Description: * Dosage:Fresh frozen plasma (FFP) will be administered at a dose of 10-15 mL/kg body weight. * Administration: The FFP will be transfused intravenously under controlled clinical conditions. * Purpose: The transfusion aims to correct coagulopathy and normalize activated partial thromboplastin time (aPTT) in non-bleeding thrombocytopenic dengue patients. * Monitoring: Patients will be closely monitored for any adverse reactions or complications during and after the transfusion process. Coagulation parameters, including aPTT, will be measured at baseline, 24 hours, and 48 hours post-transfusion.

Arm 1: Intervention Arm Title: Plasma Transfusion.; Arm 2: Control Arm Title: Standard Supportive Care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with dengue fever, thrombocytopenia (platelet count \< 100,000/μL), and elevated aPTT (\> 40 seconds) without active bleeding.

You may not qualify if:

• Patients with active bleeding, known coagulopathies unrelated to dengue, or contraindications to plasma transfusion.

Sponsors & Collaborators

• Sheikh Hasina National Institute of Burn and Plastic Surgery: lead

Study Sites (1)

SheikhHasinaNIBPS

Dhaka, 1205, Bangladesh

Location

Related Publications (8)

• Lye DC, Lee VJ, Sun Y, Leo YS. Lack of efficacy of prophylactic platelet transfusion for severe thrombocytopenia in adults with acute uncomplicated dengue infection. Clin Infect Dis. 2009 May 1;48(9):1262-5. doi: 10.1086/597773.

  PMID: 19292665 RESULT

• Wills BA, Oragui EE, Dung NM, Loan HT, Chau NV, Farrar JJ, Levin M. Size and charge characteristics of the protein leak in dengue shock syndrome. J Infect Dis. 2004 Aug 15;190(4):810-8. doi: 10.1086/422754. Epub 2004 Jul 19.

  PMID: 15272410 RESULT

• Malavige GN, Velathanthiri VG, Wijewickrama ES, Fernando S, Jayaratne SD, Aaskov J, Seneviratne SL. Patterns of disease among adults hospitalized with dengue infections. QJM. 2006 May;99(5):299-305. doi: 10.1093/qjmed/hcl039. Epub 2006 Apr 7.

  PMID: 16603571 RESULT

• Martina BE, Koraka P, Osterhaus AD. Dengue virus pathogenesis: an integrated view. Clin Microbiol Rev. 2009 Oct;22(4):564-81. doi: 10.1128/CMR.00035-09.

  PMID: 19822889 RESULT

• Mackenzie JS, Gubler DJ, Petersen LR. Emerging flaviviruses: the spread and resurgence of Japanese encephalitis, West Nile and dengue viruses. Nat Med. 2004 Dec;10(12 Suppl):S98-109. doi: 10.1038/nm1144.

  PMID: 15577938 RESULT

• Bhatt S, Gething PW, Brady OJ, Messina JP, Farlow AW, Moyes CL, Drake JM, Brownstein JS, Hoen AG, Sankoh O, Myers MF, George DB, Jaenisch T, Wint GR, Simmons CP, Scott TW, Farrar JJ, Hay SI. The global distribution and burden of dengue. Nature. 2013 Apr 25;496(7446):504-7. doi: 10.1038/nature12060. Epub 2013 Apr 7.

  PMID: 23563266 RESULT

• Guzman MG, Harris E. Dengue. Lancet. 2015 Jan 31;385(9966):453-65. doi: 10.1016/S0140-6736(14)60572-9. Epub 2014 Sep 14.

  PMID: 25230594 RESULT

• undefined

  RESULT

MeSH Terms

Conditions

Dengue; Severe Dengue; Thrombocytopenia

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral; Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Study Officials

• Ashraful Hoque, DBST

  Sheikh Hasina National Institute of Burn & Plastic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: In this model, participants are randomly assigned to one of two or more groups (arms) simultaneously, with each group receiving a different intervention or control treatment. The outcomes of each group are then compared to assess the efficacy and safety of the interventions.

Study Record Dates

• First Submitted: October 13, 2024
• First Posted: October 15, 2024
• Study Start: May 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After 1st Novembar, 2024
• Access Criteria: Access to de-identified individual participant data (IPD) will be granted to researchers who meet the following criteria: Scientifically Sound Proposal: Researchers must submit a valid scientific proposal outlining the objectives and methodology, subject to review by the study's steering committee. Ethics Approval: A valid ethics committee or IRB approval for secondary use of the data must be provided. Data Use Agreement (DUA): Researchers must sign a DUA ensuring data use is limited to approved purposes, maintains participant privacy, and follows data security measures. Non-commercial Use: Data access is limited to academic and public health research, not for commercial purposes. Publication: Researchers agree to publish their findings in peer-reviewed journals or other public formats. Security: Data must be handled in compliance with relevant privacy regulations.

Locations

BA (1)